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The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.

The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.

The CCPoint® test is a colloidal gold based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone.

The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad.

In the assay procedure, a sample of serum or plasma is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After a short incubation running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane.

If the sample contains anti-CCP antibodies they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain any anti-CCP antibodies no line will appear. With any sample a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active.

Here's a breakdown of the acceptance criteria and the study details for the CCPoint® kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device (Immunoscan RA anti-CCP test kit) and providing clinical performance metrics. Explicit "acceptance criteria" for the CCPoint® beyond achieving substantial equivalence and acceptable clinical performance are not explicitly stated as numerical targets in the same way one might see for a completely novel device claim. However, the reported performance serves as the basis for the FDA's substantial equivalence determination.

Implied Acceptance Criteria / Performance Benchmarks (derived from the predicate comparison and clinical performance):

2. Sample Size and Data Provenance (Test Set)

• Sample Size for Predicate Comparison (Table 1a): 1062 frozen retrospective sera.
  • 606 from RA patients
  • 456 apparently healthy blood donors
• Sample Size for Predicate Comparison (Table 1b, subset): 399 samples (extracted from Table 1a, specifically those in the range of 15-1600 U/mL with the ELISA).
• Sample Size for Clinical Sensitivity/Specificity (Table 2 & Specificity Tables): 1815 frozen retrospective sera with clinical characterization.
  • 596 patients with clinically defined RA
  • 456 Blood donors
  • 187 non-RA arthritis
  • 43 Psoriatic arthritis
  • ... (various other disease/control groups listed in the document, totaling 1815)
• Data Provenance: "frozen retrospective sera". The country of origin is not explicitly stated in the provided text.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. It mentions "Patients with clinically defined RA" and "frozen retrospective sera with clinical characterisation," suggesting that clinical diagnoses and medical records were used to categorize samples. However, there's no detail on who made or confirmed these diagnoses, nor any adjudication process by experts specifically for the study.

4. Adjudication Method (Test Set)

No adjudication method (e.g., 2+1, 3+1) is mentioned or described for establishing the ground truth of the test set. The clinical characterization appears to be based on pre-existing diagnoses in the retrospective sera.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device is a visually read rapid diagnostic test, and the performance study described is an agreement study against a predicate device and a clinical sensitivity/specificity study against clinical diagnoses. It does not evaluate human readers' improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The CCPoint® is a visually read, qualitative rapid lateral flow test. The performance data presented (percent agreements, sensitivity, specificity) reflects the output of the device itself (the presence or absence of a red line) when interpreted visually according to its intended use instructions by trained laboratory professionals. There is no separate "algorithm" being assessed independent of the visual interpretation of the test result; the visual interpretation is the algorithm's output.

7. Type of Ground Truth Used

• For Predicate Comparison (Tables 1a, 1b): The ground truth was established by the results of the predicate device, Immunoscan RA anti-CCP ELISA.
• For Clinical Sensitivity and Specificity (Table 2 and subsequent specificity tables): The ground truth was "clinical characterization" or "clinically defined RA" for the RA patient group, and diagnostic categories (e.g., "Blood donors," "non-RA arthritis," "Systemic collagen disease") for the control and disease groups. This indicates clinical diagnoses/outcomes information as the ground truth.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or "validation set" in the context of machine learning. This is a diagnostic device comparison and clinical performance study, not an AI/machine learning model development. Therefore, there's no reported sample size for a training set in that sense. The samples used for the performance evaluation are considered a test set.

9. How the Ground Truth for the Training Set was Established

As there is no mention of a traditional "training set" for an AI/ML model, this question is not applicable. The device's mechanism is a biochemical immunoassay, not a learning algorithm that requires a training phase.

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